Regulatory Affairs Manager

Gateway Search Pte Ltd; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Gateway Search Pte Ltd is seeking a Regulatory Manager in Singapore to ensure products meet local and international health regulations. You will oversee approvals, prepare documentation for health authorities, and ensure labeling and marketing comply with legal rules.

You will serve as the main liaison with HQ and APAC partners, coordinating queries, variations, submissions and registrations, while handling product issues and maintaining regulatory records.

Qualifications

• Experience handling regulatory submissions and health authority documents.
• Ability to ensure labeling and marketing comply with applicable laws.
• Strong coordination with HQ and partners across APAC.
• Pharmacovigilance training and ICSR awareness preferred.

Responsibilities

• Main liaison with HQ and Partners on Regulatory matters for APAC countries.
• Coordinate all queries, variations, submissions and registrations.
• Handle product issues, complaints, and quality issues as they arise.
• Maintain Product Data Management (PDM) records and packaging records.
• Manage dossiers, trademarks, and GTIN information for SPAP markets.
• Monitor ICSR, reporting, and documentation for SPAP products in Singapore.

Skills

Regulatory affairs

APAC coordination

Pharmacovigilance

Documentation management

Quality & compliance

Job description

We are looking for a Regulatory Manager to ensure that our products meet all local and international health regulations. You will handle product approvals, prepare documents for health authorities, and make sure our labeling and marketing follow legal rules.

Regulatory Affairs

• Main liaison personnel with Head Quarters and all Partners on Regulatory matters for APAC HQ's countries, not limited to Singapore, Malaysia, Indonesia, Philippines, Thailand, Vietnam, Australia & New Zealand.
• Coordinate all queries, variations, submissions and registrations.
• Handles product issues or complaints as well as quality issues.
• Update of PDM (Product Data Management) records and Packaging records.
• Maintain past dossiers and attend to queries relating to approved dossiers and dossier information.
• Records of trademarks for SPAP countries.
• Maintenance of GTIN (Global Trade Item Number) information for products marketed in SPAP countries.
• Individual Case Safety Report (ICSR) monitoring, reporting & documentation for SPAP products marketed in Singapore.
• Recall procedures, execution & documentation for SPAP products marketed in Singapore.
• Coordination of recall procedures, execution & documentation for SPAP products marketed in SPAP countries in accordance to local regulatory requirements.
• Quarterly reporting of weekly literature screening outcomes.
• Annual reconciliation of ICSR (Individual Case Safety Report) for Singapore.
• Coordinate with SPAP partners to reconcile the ICSR for their respective countries.
• Pharmacovigilance training.
• Main Local Safety Officer (LSO) in liaison with EU HQ.
• Submission of Product Quality Reports (PQRs) and Periodic Safety Update Reports in countries where it is legally required.